Identity
- Trade Name
- endosight EUDAMED
- Device Name
- endosight EUDAMED
- Model / Reference
- EN000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052141890073 EUDAMED
- Basic UDI-DI
- 8052141890004ENDGG9 EUDAMED
- Direct Marketing DI
- 08052141890073 EUDAMED
- EMDN Code
- Z12011492 SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The endosight device is a Class IIa medical device designed for the treatment of gastrointestinal conditions. With its advanced features and robust design, it provides reliable and accurate results in clinical settings.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8052141890004ENDGG9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- R.A.W. Srl
- EUDAMED SRN
- IT-MF-000027589
Sources (1)
- EUDAMED 6ce5fb40-a441-44eb-beff-54ad5937060d 61 fields · synced Jul 11, 2026